Clinical trials — a case for reform

I am new on Medium and my first search was for clinical trials related posts. i have worked in clinical data management and EDC since the mid 90’s and now, reading this post, I can say I have seen the entire industry (EDC and eClinical systems) come full circle.

If anyone believes anything in this post you should talk to anyone in industry that is not a new vendor in the sector. “Most” studies are not done on paper. Most trials today use EDC, IWRS and some use ePRO/eCOA. There is no way to decrease costs by 30%-40% by implementing direct data capture/eSource or EDC — it never has and simply can’t since data management costs are rarely more than 20% of the study budget — how then do you reduce trial costs by more than you spend? Using eSource rarely decreases monitoring costs since the travel and lodging costs don’t go away and the CRA or other monitor will still visit sites for reasons other than SDV. And finally — these systems have not shown to have any impact on the cost of drug development. By the time we start using EDC in Phase III trial the bulk of the R&D budget has already been spent in discovery, failed products and all the other “hidden” costs that make up the bulk of the oft-quoted $1B cost of development.

The most recent study budget I worked on had a $60M budget for a large, multi-country 6000 subject Phase III study. The data management budget was less than $5MM. How can you ever see “ 30%-40% savings on trial costs” when these are the actual costs? (And note — this study is using EDC — we always do).

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